Agomelatine

Description

Agomelatine is an antidepressant medication used in the treatment of depression (a mood disorder that involves persistent feelings of sadness and loss of interest in daily activities) in adults. Agomelatine works by increasing the levels of a chemical substance in your brain, which helps to improve mood and reduce the feeling of anxiety. Agomelatine causes side effects such as nausea, diarrhoea or constipation, headache, drowsiness, dizziness, changes in the sleeping pattern, increased levels of liver enzymes, and tiredness. Consult your doctor if these symptoms persist or worsen. Avoid taking this medicine if you are allergic to it. Agomelatine may be taken with or without food as directed by your doctor. Take it at the same time every day for the ease of remembering. Do not stop taking Agomelatine without consulting your doctor, as it may cause withdrawal symptoms. Agomelatine can alter your mood and cause suicidal thoughts. Therefore, closely observe for any change in your mood or behaviour while you take this medicine. Consult your doctor immediately if you experience such symptoms. Agomelatine is not recommended for use if you have active liver problems as it may further worsen your condition. Also, inform your doctor if you are taking any other medications or have any other medical conditions to avoid undesired effects. Agomelatine is not recommended for use in children below 18 years of age and the elderly above 65 years of age as the safety and efficacy data are not clinically established. Consult your doctor if you are pregnant or are breastfeeding.

Side effects

Major & minor side effects for Agomelatine

  • Headache
  • Dizziness
  • Sleepiness
  • Nausea
  • Diarrhea
  • Constipation
  • Abdominal pain
  • Tiredness
  • Anxiety
  • Abnormal dreams
  • Increase in liver enzyme levels
  • Weight gain
  • Blurred vision
  • Ringing or buzzing in the ears
  • Severe skin rash and hives
  • Aggression or anger
  • Swelling of the face, arms, hands, lower legs, or feet
  • Yellowing of skin and eyes

Uses of Agomelatine

What is it prescribed for?

  • Depression
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Concerns

Commonly asked questions

  • Onset of action
    The amount of time taken by Agomelatine to show its effect is not clinically established.
  • Duration of effect
    The amount of time for which Agomelatine remains effective in your body is not clinically determined.
  • Safe with alcohol?
    Consumption of alcohol is not recommended during treatment with Agomelatine due to the increased risk of liver injury and other side effects.
  • Is it habit forming?
    No habit-forming tendencies were reported for Agomelatine.
  • Usage in pregnancy?
    Agomelatine is not recommended for use during pregnancy due to the lack of sufficient safety data. Hence, consult your doctor if you are pregnant.
  • Usage while breast-feeding?
    It is not known whether Agomelatine passes into the breastmilk. Hence, it is not recommended for use if you are breastfeeding.

Allergy

Avoid taking Agomelatine if you are allergic to it. Seek immediate medical attention if you notice any symptoms such as oedema (swelling of the hands, feet, ankles, face, lips), difficulty in swallowing or breathing, or severe skin rashes, redness, and itching.

Liver impairment

Agomelatine is not recommended for use if you have active liver problems due to the increased risk of liver toxicity.

CYP1A2 inhibitors

CYP1A2 inhibitors are medicines that block the action of an enzyme in the body that is responsible for the breakdown of certain medicines. Agomelatine is not recommended for use if you are concomitantly taking strong CYP1A2 inhibitors such as Fluvoxamine, Ciprofloxacin, etc., due to the increased risk of undesired effects.
Warnings for special population

Pregnancy

Agomelatine is not recommended for use during pregnancy due to the lack of sufficient safety data. Hence, consult your doctor if you are pregnant.

Breast-feeding

It is not known whether Agomelatine passes into the breastmilk. Hence, it is not recommended for use if you are breastfeeding.
General warnings

Other medicines

Agomelatine may interact with other medicines and cause severe side effects. Hence, inform your doctor about all your current medicines, including any herbs and supplements, before beginning treatment with Agomelatine.

Use in children

Agomelatine is not recommended for use in children less than 18 years of age as the safety and efficacy data are not clinically established.

Use in elderly

Agomelatine is not recommended for use in the elderly above 65 years of age as the safety and efficacy data are not clinically established.

Suicidal thoughts

Agomelatine should be used with caution due to the increased risk of suicidal thoughts. Consult your doctor immediately if you experience changes in your mood and behaviour or develop suicidal thoughts.

Smoking

Excessive smoking ( especially more than 15 cigarettes per day) may decrease the effectiveness of Agomelatine. Hence, avoid smoking during treatment with this medicine.

Driving or operating machines

Agomelatine may cause drowsiness or dizziness. Hence, avoid driving vehicles or operating machines if you experience such symptoms during treatment with this medicine.

Liver Injury

Agomelatine should be used with caution as it may cause increased levels of liver enzymes and increase the risk of liver injury. Your doctor may suggest tests to monitor your liver function before starting the treatment and while you are taking this medicine.

Missed Dose

Take the missed dose of Agomelatine as soon as you remember. If it is time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Never take more than the prescribed dose. Seek emergency medical attention in case of an overdose of Agomelatine.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

N/A

Instructions

Consumption of alcohol is not recommended during treatment with Agomelatine due to the increased risk of liver injury and other side effects.
Interaction with Medicine

Propranolol

Estrogens

Rifampicin

Fluvoxamine

Enoxacin

Disease interactions

Dementia

Dementia is a term used to describe loss of memory, language, problem-solving, and other thinking abilities that interfere with daily life. Agomelatine should be used with caution if you have dementia, especially in the elderly with dementia, due to the lack of safety and efficacy data in such a condition.

Bipolar disorder

Mania is a mental health condition that involves a state of high energy and elevated or irritated mood. Agomelatine may occasionally cause or activate mania. Hence, it should be used with caution if you have a history of mania.
Food interactions
Information not available.
Lab interactions
Information not available.
Take Agomelatine exactly as prescribed by your doctor. Do not take in larger or smaller quantities than prescribed. You may need to undergo liver function tests before and during treatment with this medicine. Report any symptoms such as yellowing of the skin or eyes, unusual tiredness, light-coloured stools, unusual darkening of the urine, pain in the upper right belly, etc., to your doctor immediately. It may indicate that your liver is not working properly. Avoid consumption of alcohol during treatment with this medicine as it may increase the risk of liver damage. Avoid smoking during treatment with Agomelatine as it may decrease the effectiveness of this medicine.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Causes sleepiness

How it works
Agomelatine works by increasing the levels of a chemical substance in your brain and thus, helps in maintaining mental balance.
Legal Status

Approved

Unknown

Unknown

Approved

Classification

Category

Antidepressants

Schedule

Schedule H

Ema.europa.eu. 2022. [online] Available at: < [Accessed 18 February 2022].

https://www.ema.europa.eu/en/documents/product-information/valdoxan-epar-product-information_en.pdf>

Medicines.org.uk. 2022. [online] Available at: < [Accessed 18 February 2022].

https://www.medicines.org.uk/emc/files/pil.6564.pdf>

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Information on this page was last updated on 24 Feb 2022

Disclaimer

We’ve made all possible efforts to ensure that the information provided here is accurate, up-to-date and complete, however, it should not be treated as a substitute for professional medical advice, diagnosis or treatment. Practo only provides reference source for common information on medicines and does not guarantee its accuracy or exhaustiveness. The absence of a warning for any drug or combination thereof, should not be assumed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Practo does not assume any responsibility for any aspect of healthcare administered with the aid of information provided above. If you have any doubts about your medication then we strongly recommend that you consult with your doctor, nurse or healthcare provider. See detailed T&C here.